Clinical Evaluation of Vagal Nerve Preservation in Minimally Invasive Surgery for Early Lung Cancer (CEVNPIMISELC)

Tongji University

Status: Unknown

Conditions: Lung Cancer Stage I

Treatments: Other: In minimally invasive surgery，Vagus nerve is not preserved; Other: In minimally invasive surgery，Vagus nerve preservation

Study type: Interventional

Funder types: Other

Identifiers

NCT04125979

2019-LCYJ-006

Details and patient eligibility

About

Through prospective, randomized and controlled clinical study, patients with early lung cancer who do not need lymph node dissection according to routine diagnosis and treatment were selected. The feasibility and safety of preserving vagal pulmonary branch intact during minimally invasive surgery were compared with traditional minimally invasive surgery, and the feasibility and safety of preserving vagal pulmonary branch intact during minimally invasive surgery were clarified. The effect of preserving pulmonary branches of vagus nerve in minimally invasive surgery of early lung cancer on preventing or reducing pulmonary complications after operation was evaluated by main observation indexes (incidence of pulmonary complications) and secondary evaluation indexes. It will provide a safer, simpler and more effective new technology for patients with early lung cancer undergoing minimally invasive surgery, and provide a basis for the popularization of this new technology.

Full description

According to the suggestion of statistical experts and the minimum sample size, 120 IA1-2 patients who are going to undergo thoracoscopic lung surgery were selected according to the criteria of admission and exclusion. The risk and benefit were informed and the informed consent of the subjects was signed. The patients were numbered and randomly divided into two groups: group A with vagus nerve preservation during minimally invasive surgery and group B with traditional minimally invasive surgery for early lung cancer. The incidence of pulmonary complications within 5 weeks after operation (see the evaluation criteria for details), operation time, intraoperative bleeding volume, postoperative drainage volume, postoperative mortality, incidence of cardiovascular complications, rate of re-tracheal intubation, rate of re-admission to ICU, duration of stay in ICU, hospitalization costs were observed. Statistical analysis and evaluation of the safety of preserving pulmonary branches of vagus nerve in minimally invasive surgery and the effectiveness of preventing or reducing pulmonary complications after minimally invasive surgery.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (1) 18-70 years of age, regardless of gender;
• (2) From May 2019 to December 2021, patients with lung cancer who underwent thoracoscopic pneumonectomy (wedge-shaped, segment and lobe) were admitted to our hospital. Postoperative pathological diagnosis was non-small cell lung cancer. Preoperative pathological staging was T1a-bN0M0 and IA1-2 (pathological staging refers to UICC 8th Edition TNM staging standard for lung cancer).
• (3) In addition to routine examinations, all patients underwent enhanced chest CT, cranial CT/MRI, abdominal B-mode ultrasound, whole body bone isotope scan or PET-CT to exclude distant metastasis.
• (4) Subjects clearly understand the purpose of the study, are willing and able to comply with the requirements to complete the study, and sign the informed consent.

Exclusion criteria

• (1) Patients with other infectious diseases (inflammation, tuberculosis, etc.) in the thoracic cavity;
• (2) Patients are unwilling to accept the new technique of preserving pulmonary branch of vagus nerve during operation;
• (3) Clinical unstable patients with severe cardiovascular, renal and respiratory system;
• (4) Participated in other clinical trials within 30 days;
• (5) Other reasons why researchers think it is inappropriate to participate in the experiment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Preservation of pulmonary vagus nerve

Experimental group

Description:

Preservation of pulmonary branches of vagus nerve in minimally invasive surgery for lung cancer

Treatment:

Other: In minimally invasive surgery，Vagus nerve preservation

No pulmonary vagus nerve preservation

Experimental group

Description:

In minimally invasive surgery for lung cancer, the pulmonary branches of vagus nerve were severed

Treatment:

Other: In minimally invasive surgery，Vagus nerve is not preserved